Weight ControlNCT06856551
Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention
A study testing Promotion and Prevention Interventions in people with Weight Control, run by University of North Florida at 1 site in United States.
Trial summary
The study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Control
- What is being tested?
- Promotion and Prevention Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2015to 20 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ years old
- generally healthy
- BMI between 18.5 and 35
Who cannot join
- pregnancy within the past 6 months
- current pregnancy
- plan to get pregnant in the next 6 months
- serious physical or psychological problems that would contraindicate participation in a weight-related program
- history of anorexia or bulimia
- diabetes or hypertension
- current participation in a weight-loss program
- BMI < 18.5, >35.0
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Florida
Jacksonville, Florida, 32224
About this study
The study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors. The lifestyle behaviors of interest included meal regularity, self-monitoring of diet and physical activity, fast-food eating, screen related viewing and eating, dietary modifications, self-weighing, and physical activity. It was hypothesized that increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity would lead to better weight control over six months. Conversely, it was hypothesized that increases in fast food consumption and screen related eating and viewing would lead to poorer weight control over six months. It was expected that promotion and prevention conditions, relative to the control condition, would lead to better weight control and increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity, and decreases in fast food consumption and screen related eating and viewing. Furthermore, it was expected that the promotion condition would lead to better outcomes than the prevention condition.
- Conditions
- Weight Control
- Being tested
- Minimal contact control, Promotion and Prevention Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal contact controlBehavioural
Participants in the control group received a pamphlet about general dietary and physical activity guidelines.
Promotion and Prevention InterventionsBehavioural
regulatory focus groups, participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses. Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal). The informational content and intervention procedures were identical except for the framing of messages and tasks. The prevention messages emphasized protecting one's health (e.g., failing to regularly exercise can undermine your weight control program and lead to poor health; if you do not vigilantly follow these behaviors, you will not fulfill your weight control goals or protect your health and well-being; not eating fruits and vegetables results in failure to supply the body with the nutrients it needs). The promotion messages emphasized promoting one's health
| Study group | Role | What they receive |
|---|---|---|
| Minimal contact control | Active comparator | Participants in the control group received a pamphlet about general dietary and physical activity guidelines. Receives: Behavioral: Minimal contact control |
| Promotion focus group | Experimental | Participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses. Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal). All messages and study tasks were framed in terms of promotion focus. Email messages were sent every 2 to 3 weeks to reinforce the study messages about health promotion and weight control. Receives: Behavioral: Promotion and Prevention Interventions |
| Prevention focus group | Experimental | Participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses. Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal). All messages and study tasks were framed in terms of prevention focus. Email messages were sent every 2 to 3 weeks to reinforce the study messages about health promotion and weight control. Receives: Behavioral: Promotion and Prevention Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Participant were weighed by study staff during a baseline measurement session (M = 153.7 lb, SD = 31.6) and then again after 6 months (M = 149.9 lb, SD = 28.9). Weight was self-reported at 3 months (M = 150.7 lb, SD = 29.4).
Measured: baseline, 3 months, 6 months
Secondary outcomes (7)
meal regularity change
Participants were asked about the number of times in a typical week they 1) ate breakfast, 2) ate lunch, and 3) ate dinner. They responded on a 5-point scale: 0 times, 1-2 times, 3-4 times, 5-6 times, or 7+ times. Mean scores were created for the baseline measurement session (M = 4.00, SD = .73) and for the 3-month measurement session (M = 4.17, SD = .72).
Measured: baseline, 3 months
fast-food eating change
Participants were asked about the number of times in a typical week they 1) ate food prepared at a fast-food restaurant and 2) purchased food at a convenience store/ gas station. They responded on a 5-point scale: 0 times, 1-2 times, 3-4 times, 5-6 times, or 7+ times. Mean scores were created for the baseline measurement session (M = 1.74, SD = .66) and for the 3-month measurement session (M = 1.63, SD = .53).
Measured: baseline, 3 months
screen related eating and viewing change
Participants indicated the frequency per week that they 1) ate a meal while watching TV, 2) ate a snack while watching TV, and 3) ate after 8 pm. The participants responded by using a 5-point scale: 0 times, 1-2 time, 3-4 times, 5-6 times, or 7+ times. They also indicated the number of hours on an average day that they 4) use a phone/tablet/computer, 5) watch TV and 6) sit or recline (not including sleeping). Their responses were recorded on a 7-point scale: 0, <1 hour, 1 hour, 2 hours, 3 hours, 4 hours, or 5+ hours. Mean scores across the six items were calculated for the baseline measurement session (M = 3.44, SD = .90) and the 3-month measurement session (M = 3.34, SD = .90).
Measured: baseline, 3 months
dietary modifications change
Dietary modification was measured by asking participants how often they 1) reduced/limited their portions, 2) decreased/limited snacks, 3) decreased/limited sweets, 4) decreased/limited fried food, 5) decreased/limited carbs, 6) decreased/limited fat, 7) ate fruits and vegetables, and 8) planned meals. Participants responded on a 5-point scale: never, rarely, sometimes, often, or very often. Mean scores were calculated for the baseline measurement session (M = 2.96, SD = 0.74) and for the 3-month measurement session (M = 3.32, SD = 0.73).
Measured: baseline, 3 months
self-monitoring change
For self-monitoring, participants were asked how often they wrote down the calorie content of the foods they ate and the amount and types of exercise they did. Participants responded on a 5-point scale: never, rarely, sometimes, often, or very often. Mean scores were then calculated for the baseline measurement session (M = 1.86, SD = 1.03) and for the 3-month measurement session (M = 2.85, SD = 1.26).
Measured: baseline, 3 months
self-weighing change
At baseline, participants responded to the question "How often do you weigh yourself?" on a 7-point scale: never, about once a year or less, every couple of months, every month, every week, every day, or more than once a day (M = 3.83, SD = 1.31). At 3 months, they responded to the question "In the past week, how many times did you weigh yourself?" on a 5-point scale: never, 1-2 times, 3-4 times, 5-6 times, or 7 or more times (M = 2.01, SD = 1.02).
Measured: baseline, 3 months
physical activity change
To measure physical activity, participants were asked how often they 1) planned their exercise, 2) walked for at least 30 minutes at a time, and 3) engaged in other moderate to vigorous exercise. Participants responded on a 5-point scale: never, rarely, sometimes, often, or very often. Mean scores were calculated for the baseline measurement session (M = 3.31, SD = .94) and for the 3-month measurement session (M = 3.55, SD = 1.08).
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start30 Oct 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Fuglestad, University of North Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856551
- Sponsor's protocol ID
- 724308
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared on open science framework.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention
- ClinicalTrials.gov ID
- NCT06856551
- Acronym / sponsor ID
- 724308
- Conditions
- Weight Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North FloridaUniversity, hospital or other
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors. The lifestyle behaviors of interest included meal regularity, self-monitoring of diet and physical activity, fast-food eating, screen related viewing and eating, dietary modifications, self-weighing, and physical activity. It was hypothesized that increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity would lead to better weight control over six months. Conversely, it was hypothesized that increases in fast food consumption and screen related eating and viewing would lead to poorer weight control over six months. It was expected that promotion and prevention conditions, relative to the control condition, would lead to better weight control and increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity, and decreases in fast food consumption and screen related eating and viewing. Furthermore, it was expected that the promotion condition would lead to better outcomes than the prevention condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minimal contact control | Active comparator | Behavioral: Minimal contact controlParticipants in the control group received a pamphlet about general dietary and physical activity guidelines. |
| Promotion focus group | Experimental | Behavioral: Promotion and Prevention InterventionsParticipants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses. Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal). All messages and study tasks were framed in terms of promotion focus. Email messages were sent every 2 to 3 weeks to reinforce the study messages about health promotion and weight control. |
| Prevention focus group | Experimental | Behavioral: Promotion and Prevention InterventionsParticipants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses. Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal). All messages and study tasks were framed in terms of prevention focus. Email messages were sent every 2 to 3 weeks to reinforce the study messages about health promotion and weight control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years old
- generally healthy
- BMI between 18.5 and 35
Key exclusion criteria (8 listed)
- pregnancy within the past 6 months
- current pregnancy
- plan to get pregnant in the next 6 months
- serious physical or psychological problems that would contraindicate participation in a weight-related program
- history of anorexia or bulimia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal contact controlParticipants in the control group received a pamphlet about general dietary and physical activity guidelines. | Behavioural | Minimal contact control |
| Promotion and Prevention Interventionsregulatory focus groups, participants completed a 1-hour educational information session with study staff and received a packet which contained information about energy balance, healthy food choices, exercise recommendations, strategies for weight control, goal setting, and responding to lapses. Participants were encouraged to track their food intake and exercise with a provided log book or free apps (Lose It!; MyFitnessPal). The informational content and intervention procedures were identical except for the framing of messages and tasks. The prevention messages emphasized protecting one's health (e.g., failing to regularly exercise can undermine your weight control program and lead to poor health; if you do not vigilantly follow these behaviors, you will not fulfill your weight control goals or protect your health and well-being; not eating fruits and vegetables results in failure to supply the body with the nutrients it needs). The promotion messages emphasized promoting one's health | Behavioural | Prevention focus group, Promotion focus group |
Primary outcome
Weight Change
Time frame: baseline, 3 months, 6 months
Participant were weighed by study staff during a baseline measurement session (M = 153.7 lb, SD = 31.6) and then again after 6 months (M = 149.9 lb, SD = 28.9). Weight was self-reported at 3 months (M = 150.7 lb, SD = 29.4).
7 secondary outcomes
meal regularity change
Time frame: baseline, 3 months
fast-food eating change
Time frame: baseline, 3 months
screen related eating and viewing change
Time frame: baseline, 3 months
dietary modifications change
Time frame: baseline, 3 months
self-monitoring change
Time frame: baseline, 3 months
self-weighing change
Time frame: baseline, 3 months
physical activity change
Time frame: baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. Will be shared on open science framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion and Prevention Interventions in people with Weight Control, run by University of North Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.